An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49837
• EU PAS number:
  EUPAS49836
• Study ID:
  49837
• Official title and acronym:
  An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Retrospective observational study using health insurance claimsin the United States to access the risk of developing pre-specified adverse events of special interest,following sdministration of Ad26.COV2.S.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Harvard Pilgrim Health Care Institute

HealthCore

Optum

Germany

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

CVS Health (Aetna), Hartford, Connecticut, USA
Humana, Louisville, Kentucky, USA

Study timelines

Date when funding contract was signed

Planned: 04/03/2021

Actual: 04/03/2021

Study start date

Planned: 01/04/2021

Actual: 01/04/2021

Date of final study report

Planned: 31/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

VAC31518COV4001